Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Fred Hutchinson Cancer Center (FHCC)

Status: Terminated

Conditions: Stage IV Small Lymphocytic Lymphoma; Stage III Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Splenic Marginal Zone Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Adult Acute Myeloid Leukemia in Remission; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Stage III Grade 3 Follicular Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Recurrent Mantle Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Stage I Multiple Myeloma; Blastic Phase Chronic Myelogenous Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Stage III Adult Diffuse Large Cell Lymphoma; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Recurrent Small Lymphocytic Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Accelerated Phase Chronic Myelogenous Leukemia; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Stage III Multiple Myeloma; Stage III Marginal Zone Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Noncontiguous Stage II Adult Burkitt Lymphoma; Chronic Phase Chronic Myelogenous Leukemia; Refractory Hairy Cell Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Recurrent Adult Hodgkin Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Refractory Multiple Myeloma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Previously Treated Myelodysplastic Syndromes; Relapsing Chronic Myelogenous Leukemia; Recurrent Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; de Novo Myelodysplastic Syndromes; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Stage IV Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Adult Acute Lymphoblastic Leukemia in Remission; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Secondary Myelodysplastic Syndromes; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Noncontiguous Stage II Grade 3 Follicular Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Secondary Acute Myeloid Leukemia; Recurrent Adult Acute Myeloid Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL Negative; Stage IV Grade 1 Follicular Lymphoma; Stage II Multiple Myeloma

Treatments: Procedure: allogeneic hematopoietic stem cell transplantation; Drug: plerixafor; Biological: filgrastim; Procedure: peripheral blood stem cell transplantation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01076270

NCI-2010-00252 (Registry Identifier)

2385.00

Details and patient eligibility

About

RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for mobilization of donor peripheral blood stem cells before a peripheral blood stem cell transplant in treating patients with hematologic malignancies

Full description

PRIMARY OBJECTIVES:

I. The percentage of normal donors who collect at least 2 x 10^6 CD34 cells/kg recipient weight on day 1 after administration of combined filgrastim and plerixafor.

SECONDARY OBJECTIVES:

I. Measuring CD34+ cells/ul in peripheral blood of donors 11, 15, 24 and 36 hours post dosing.

II. Tolerance and safety of combined filgrastim and Plerixafor in normal donors.

III. Engraftment of filgrastim/plerixafor mobilized stem cells in allogeneic recipients.

IV. Acute and chronic graft-versus-host disease (GVHD) following the use of filgrastim/plerixafor mobilized stem cells.

V. Yield of CD34+ cells based on donor weight.

OUTLINE: Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.

After completion of study treatment, donors are followed up 1 day after the last stem cell donation.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hematologic malignancy considered eligible and suitable for allogeneic stem cell transplantation (syngeneic transplantation is acceptable); diagnoses include acute myeloid or lymphoid leukemias, chronic myeloid or lymphoid leukemias, multiple myeloma, lymphoma or myelodysplasia; subjects suitable for this study will primarily receive transplant on a standard treatment plan (non research regimen)
• Organ function, performance status and age suitable for an ablative regimen consisting of TBI >= 10Gy or a chemotherapy regimen consisting of busulphan and cyclophosphamide (BuCY) or busulphan and melphalan (BuMel)
• Availability of a fully matched sibling donor
• Ability to understand and willingness to sign an informed consent
• No uncontrolled infections
• DONOR: Human leukocyte antigen (HLA) identical sibling donor
• DONOR: >= 18 years
• DONOR: No unacceptable risk to donor due to pre-existing illness
• DONOR: Must have suitable antecubital veins for leukapheresis venipuncture; donors who will require a temporary, Mahurkar-type catheter are not eligible
• DONOR: Ability and willingness to sign an informed consent document

Exclusion criteria

• Eligible for and willingness to participate in any research study of transplant regimens
• Eligible for and willingness to participate in a non ablative transplant regimen
• Human immunodeficiency virus (HIV) seropositive
• Pregnancy
• DONOR: HIV seropositive
• DONOR: Contraindication or hypersensitivity to filgrastim or plerixafor
• DONOR: Hepatitis A, B, C seropositive
• DONOR: Pregnant or lactating females
• DONOR: Liver function studies > 2 times the upper limit of normal (ULN) at evaluation, Creatinine > 2, pulmonary function diffusing lung capacity for carbon monoxide (DLCO) < 50% (if specifically evaluated), cardiac ejection fraction < 50% (if specifically evaluated)
• DONOR: Any known ventricular arrhythmia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Filgrastim and plerixafor for PBSC mobilization

Experimental group

Description:

Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation.

Treatment:

Procedure: peripheral blood stem cell transplantation

Procedure: allogeneic hematopoietic stem cell transplantation

Biological: filgrastim

Drug: plerixafor